Recruiting

Histotripsy & Chemotherapy

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT07044362

Conditions

Colorectal Cancer

Liver Metastases

Liver Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HistoSonics Edison® System

Chemotherapy

Study Details

Brief summary:

The goal of this clinical trial is to learn if histotripsy plus chemotherapy works to treat unresectable, bilobar liver- confined colorectal cancer liver metastasis (CRLM). The main question this clinical trial aims to answer is:

• Does the management of this condition with uninterrupted palliative chemotherapy and histotripsy demonstrate improved progression-free survival?

Participants will:

  • Receive chemotherapy treatment per standard procedure.
  • Undergo histotripsy treatment according to current standard procedures at Cleveland Clinic.
  • Occasionally receive Computerized Tomography (CT) scan with and without contrast, give biopsy of treated and untreated liver lesions, and participate in a blood draw of up to 3 teaspoons at each in-person visit.
  • Participate in genetic testing, as a part of the standard of care for the treatment.

Conditions

Colorectal Cancer

Liver Metastases

Liver Cancer

Study ID

NCT07044362

Start date

Jun 30, 2025

Status verified date

Mar, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants with liver-confined colorectal cancer liver metastasis (CRLM) or participants who have low-volume pulmonary disease along with CRLM
  • Participants receiving first line therapy with base of 5-FU with either oxaliplatin or irinotecan, or who are within 3 months of beginning chemotherapy, or participants who have completed chemotherapy treatment within 1 month of the histotripsy evaluation
  • Participants who have undergone other liver-directed therapy, such as ablation, embolization
  • Participants with multiple unresectable metastases that cannot be completely treated with resection and/or ablation
  • Participants aged ≥18 years

Exclusion Criteria:

  • Participants with resectable disease
  • Participants with non-pulmonary extra-hepatic disease including but not limited to bone or peritoneal metastasis.
  • Participants who are not able to tolerate general anesthesia
  • Participants who have Childs C Cirrhosis
  • Other non-skin malignancy within 2 years of study
  • WBC count < 3,000 /uL
  • Absolute Neutrophil Count < 1,500 /uL
  • History of Non-malignant serious concurrent illness that would increase the risk of histotripsy
  • Participants with MSI-High
  • Participants aged < 18 years
  • Pregnant participants

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Histotripsy + Chemotherapy

All enrolled participants will undergo combined treatment with Histotripsy and chemotherapy without interruption in the chemotherapy.

Interventions

HistoSonics Edison® System

Histotripsy is a novel, totally non-invasive, non-ionizing, and non-thermal ablation technique that mechanically disrupts tumors through precisely controlled acoustic cavitation. Histotripsy is administered via HistoSonics Edison® System.

Chemotherapy

Chemotherapy (standard of care with first line therapy of base of 5-FU with either oxaliplatin or irinotecan).

Primary outcome measure

  • Radiologic tumor viability [ Time Frame: 90 days post-treatment ]

Central Contacts and Locations

Central contacts

Federico Aucejo, MD

216-445-7159Aucejof@ccf.org

Erlind Allkushi

216-444-0223ALLKUSE2@ccf.org

Locations

Cleveland Clinic, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44195

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • Histotripsy
  • Liver-confined
  • Liver colorectal cancer liver metastasis
  • Liver-confined colorectal cancer liver metastasis
  • Chemotherapy
  • Advanced Colorectal
  • Advanced Colorectal Liver Metastasis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-03-19.